Kornimate/medical-research-clean huggingface dataset:
evaluating the efficacy of ai-guided (genais tm) vs. standard physician-guided dietary supplement prescriptions for weight loss in obese patients

Conditions: Obesity

Summary: obesity, a chronic disease characterized by excessive fat accumulation, significantly impacts health. genetic factors influence the development of obesity by affecting behavioral, dietary habits, and metabolic processes. this study investigated whether dietary supplements (ds), personalized through genetic and metabolic profiling, could enhance weight loss when combined with physical activity and dietary changes. the objective was to compare the efficacy of standard physician-guided ds prescriptions with ai-guided ds prescriptions in promoting weight loss in obese patients. the hypothesis was that ai-guided ds prescriptions, utilizing detailed genetic and metabolic data, would be more effective in promoting weight loss than standard physician-guided ds prescriptions. this was a 6-month randomized, controlled pilot clinical trial with an additional 6-month follow-up. participants were healthy individuals aged 40-60 years with a bmi of 25 or greater. participants were excluded if they had significant medical conditions or recent changes in medication or supplements. they were randomly assigned to either the control group (physician-guided ds prescriptions) or the ai-guided group (ai-determined ds prescriptions). the ai system developed by triangel scientific analyzed genetic, metabolic, and biochemical data to personalize treatment. baseline measurements included comprehensive metabolic panels, genetic testing, metabolomic profiling, and detailed patient history


Eligibility criteria:
inclusion criteria: * healthy participants aged between 40 and 60 years. * bmi of 25 or greater and no more than a 3% change in body mass within the last three months. exclusion criteria: * individuals who have taken any prescribed medications or dietary supplements in the two weeks prior to the study. * those with a clinically significant history of major digestive, liver, kidney, cardiovascular, hematological diseases, diabetes, gastrointestinal disorders, or any other serious acute or chronic medical conditions.

Keywords: dietary supplements ai-guided prescriptions genetic profiling metabolic profiling
impact of weight loss following bariatric surgery on pulmonary function in patients with morbid obesity

Conditions: Bariatric Surgery; Obesity; Respiratory Diseases

Summary: increase in body mass index (bmi)is associated with a decrease in expiratory flows.obesity is also associated with an increased prevalence of asthma.consequences of obesity on respiratory function and on bronchial responsiveness are still to be documented. this study aims to evaluate, before and after surgery, the impact of a bariatric surgery (biliopancreatic diversion with duodenal switch)on respiratory function in patients with morbid obesity . our hypothesis is that weight loss following bariatric surgery will induce significant improvements in pulmonary function and airway responsiveness, and, as a consequence, a reduction in respiratory symptoms,these changes being correlated with a reduction in systemic markers of inflammation. maintenance of weight loss after one year will permit the persistence of these improvements

patients will be evaluated before the surgery (time zero), 6 months and one year after their surgery. a control group of patients on a waiting list for bariatric surgery will be evaluated at time zero and after 6 months and one year. at each visit,patients will: * fill a standardized respiratory questionnaire and a questionnaire on sleep apnea; questionnaires on asthma control will be completed by patients with asthma. * have a spirometry, pulmonary volumes measures by body plethysmography and methacholine inhalation test with evaluation of symptoms perception. * an induced sputum will be performed. * a blood sample will be drawn to evaluate inflammation and measure c-reactive protein concentration in plasma. * an allergy skin prick test will be done at time zero.

Eligibility criteria:
inclusion criteria: * body mass index \>or= 35 kg/m2 * non-smokers or ex-smokers (\<10 packs-year) exclusion criteria: * previous bariatric surgery * previous vagotomy * no compliance to visits * subjects unable to provide an informed consent or to understand the questions included in questionnaires * patients with cardiac pacemaker * hemodynamically significant valvulopathy
the safety and immunogenicity of dtp/hepatitis b 10ug hib vaccine (bio farma)

Conditions: Healthy

Summary: the objective of this study was to know the safety of dtp/hepatitis b and hib/prp-t vaccine and immediate reactions within the first 30 minutes after injection.

this trial was an open-label study, no randomization, and no placebo or control group. total 30 healthy infants (age 6-11 weeks) followed this trial. the safety was assessed within 24 hours, 48 hours, 72 hours, and 28 days after injection.

Eligibility criteria:
inclusion criteria: * infant 6-11 week of age * infant born after 37-42 week of pregnancy * infant weighting more than 2.5 kg at birth * father, mother or legally acceptable representative properly informed about the study and having signed the informed consent form * parents commit themselves to comply with the indication of the investigator and with the schedule of the trial exclusion criteria: * child concomitantly enroll or schedule to be enroll in another trial * evolving moderate or severe illness, especially infectious diseases or fever (axillary temperature \>=37.5 celsius on day 0) * known history of allergy to any component of the vaccine component (e.g.formaldehyde) * history of uncontrolled coagulopathy or blood disorder contraindicating intramuscular injection * known history of congenital or acquired immunodeficiency (including hiv infection) * child who has received in the previous 4 weeks a treatment likely to alter the immune response (intravenous immunoglobulin, blood derived product or long term corticotherapy (\>2 minggu) * other vaccination within the 7 days prior to inclusion with the exception of bcg and poliomyelitis * any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objective * infant with a known history of diphteria, tetanus, pertussis, hib, hepatitis b infection

Keywords: dtb/hb/hib vaccine infants phase i
informative value of determining the level of nf-κb translocation in lymphocyte populations in children with psoriasis

Conditions: Psoriasis Vulgaris

Summary: this study is the first to quantify the level of nf-kb translocation in lymphocyte populations in children and adolescents with psoriasis of varying severity.

this is a diagnostic study aimed at finding immunological predictors of the effectiveness of therapy in children and adolescents with psoriasis. the study included 90 patients from 1 to 18 years old with psoriasis vulgaris, mild / moderate and severe. the comparison group consisted of 30 healthy children. the study took into account the pasi (psoriasis area severity index); the bsa (body surface area); including patient age; duration of the disease; type of therapy; duration of therapy. depending on the type of therapy, all psoriatic children were divided into 3 groups: group 1 (n = 24) - patients receiving basic and external therapy; group 2 (n = 20) - patients receiving systemic therapy with methotrexate; and group 3 (n = 46) - patients receiving therapy with genetically engineered biological drugs (adalimumab, etanercept, ustekinumab). the analysis of the nf-κb translocation level in lymphocytes was performed by flow cytometry with imaging (image stream mark ii - amnis) using the amnis nf-κb translocation kit.

Eligibility criteria:
inclusion criteria: 1. age from 1 to 18 years old 2. mild, moderate, and severe psoriasis 3. healthy children, as a comparison group 4. patients receiving basic and external therapy, receiving systemic therapy with methotrexate and patients receiving therapy with biological drugs (adalimumab, etanercept, ustekinumab) 5. a signed and dated informed consent received from the patient's parents (guardians), as well as from a patient over 14 years of age, to participate in the study 6. ability to attend control visits within the specified time frame exclusion criteria: 1. the presence of other concomitant skin diseases in the present or in the past, which could affect the assessment of the effect of the study drugs on the course of psoriasis 2. use of other genetically engineered biological preparations in therapy 3. participation in other clinical trials 4. extensive or complete disability, significantly limiting personal care or determining the inability to carry it out 5. immunodeficiency disease 6. the presence in the past or present of any serious and / or unstable concomitant disease 7. the course of a viral, bacterial, fungal or parasitic infection

Keywords: nf-κb translocation lymphocytes flow cytometry with imaging (amnis) biological drugs сhildren and adolescents
t and b cells in graves' orbitopathy

Conditions: Graves Ophthalmopathy

Summary: graves orbitopathy (go) is an inflammatory eye disease associated in 95% of patients with graves' hyperthyroidism (gh), in \~3-4% with hypothyroid autoimmune thyroiditis, and in \~1-2% with thyroid autoimmunity in the absence of thyroid dysfunction, the former known as euthyroid go. the pathogenesis of go is autoimmune, with the tsh-receptor being considered the major autoantigen, thereby establishing a pathogenetic link between the thyroid and orbital tissue. thus, tsh-receptor is expressed by orbital fibroblasts, where it forms a complex with the igf-1 receptor. unlike gh, which is notoriously caused by tsh-receptor stimulating autoantibodies, go is believed to reflect cell-mediated autoimmunity, as suggested by studies showing a th1-like pattern of cytokine release by primary cultures of orbital infiltrating lymphocytes from go patients. on the other hand, a role of b lymphocytes has emerged in recent years based on the observation that the anti-cd20 monoclonal antibody rituximab has a beneficial effect on go activity, as demonstrated by a recent randomized clinical trial in which rituximab was compared with intravenous glucocorticoids (gc), being the former the standard treatment of moderately-severe go. the explanation for the findings was that b lymphocytes are involved in the pathogenesis of go as antigen-presenting cells. however, in spite of the above mentioned promising observations, another randomized clinical trial in which rituximab was compared with placebo provided opposite results. thus, rituximab had no effect at all on go. data from the two studies were confronted and major differences between the two cohorts emerged, especially concerning go activity, leading to the conclusion that rituximab may be effective for active, but not for inactive go. rituximab has been employed also for autoimmune diseases other than go, including type 1 diabetes. in the former, it was shown that the effectiveness of rituximab paralleled the presence of cd20-positive infiltrating lymphocytes in pancreas islets. we therefore postulated that something similar may occur in go, because of which we planned the present, perspective, observational study, aimed at determining the presence and immunohistochemical features of lymphocytes infiltrating orbital tissues in patients with go and to relate them with the clinical features of go.


Eligibility criteria:
inclusion criteria: * patients with graves' orbitopathy subjected to orbital decompression exclusion criteria: * none
a study to evaluate ono-4474 in patients with pain due to osteoarthritis of the knee

Conditions: Osteoarthritis, Knee; Pain

Summary: the purpose of this phase 2, randomised, double-blind, placebo controlled, parallel group, multicentre study is to investigate the efficacy, safety, tolerability and pharmacokinetics of a compound ono-4474 in patients with moderate to severe pain due to osteoarthritis of the knee following 4 weeks of oral administration of ono-4474.


Eligibility criteria:
inclusion criteria: * symptomatic oa of the knee for ≥3 months diagnosed prior to screening as per american college of rheumatology clinical criteria. * radiographic evidence of tibiofemoral oa of index knee (kellgren-lawrence grade 2-3), as confirmed at screening. * moderate to severe index knee pain due to oa requiring use of analgesic medication. * willing to discontinue use of all analgesic medication (aside from rescue medication) during the study. exclusion criteria: * presence of, or history of, 1. any inflammatory arthritis (e.g. gout, reactive arthritis, psoriatic arthritis, seronegative spondylarthropathy, septic arthritis, previous diagnosis of pseudogout in target joint with proven crystals on joint aspiration or elevated c-reactive protein (crp) at time of knee arthritis flare), 2. rpoa, osteonecrosis, osteoporotic fracture or any other painful joint disease other than oa, 3. secondary causes of oa; other rheumatologic or musculoskeletal conditions (e.g., rheumatoid arthritis, fibromyalgia, septic arthritis, congenital abnormality). * orthopaedic surgery of a lower extremity or any major surgery within the previous 6 months prior to visit 1 or has plans for surgical intervention during the study. * symptomatic hip oa. * a history of partial or complete joint replacement surgery in the index knee at any time or anticipating knee surgery during the study period. * significant knee injury or any knee surgery (including arthroscopy) in the index knee within 6 months prior to screening. * uncontrolled diabetes.
12- week open label treatment of refractory bipolar depression

Conditions: Bipolar Disorder

Summary: 1. determine the change in symptomatology and function in refractory bipolar depression, when treated with combination of dep+azp for a period of 12 weeks 2. determine the tolerability and safety of azp added to dep in the treatment of refractory bipolar depression

)determine the change in symptomatology and function in refractory bipolar depression, when treated with combination of dep+azp for a period of 12 weeks 2) determine the tolerability and safety of azp added to dep in the treatment of refractory bipolar depression

Eligibility criteria:
inclusion criteria: * diagnosis of bipolar disorder i or ii according to m.i.n.i. * patient has signed informed consent * male, or female who is using effective birth control if of child bearing age * age 18 and above * currently in a depressed phase, with or without psychotic features, of the illness based on dsm-iv/mini criteria * score of more than 19 on the madrs * history of treatment refractory bipolar depression as defined by failure of the depressive episode to respond to a mood stabilizer alone or a combination of 2 or more mood stabilizers or a combination of a mood stabilizer and an antidepressant exclusion criteria: * current liver disease, * illness precluding the use of depakote er * patients who have been treated with a dep and azp combination in the past * alcohol/drug dependence in the past one month * cns neoplasms, demyelinating diseases, degenerative neurological condition or active cns infection * history of seizure, known eeg with frank paroxysmal activity, known ct of brain showing gross structural abnormalities, cerebral vascular disease by history or structural brain damage from trauma * thyroid dysfunction * unstable general medical condition * require antipsychotic other than abilify

Keywords: bipolar depression refractory
phase 2 study of md-1100 acetate administered for 14 days to patients meeting criteria for chronic constipation

Conditions: Constipation

Summary: the purpose of this study is to determine the safety and gastrointestinal pharmacodynamics (stool frequency, stool consistency, stool ease of passage, stool completeness of evacuation) of md-1100 acetate administered daily for 14 days.


Eligibility criteria:
inclusion criteria: * male or non-pregnant, non-breastfeeding female, age 18-70 years old at the time of first dose; * sexually active patients of childbearing potential agree to use double-barrier birth control; * females of childbearing potential must complete negative pregnancy tests prior to first dose; * negative colonoscopy within 10 years or completion of negative flexible sigmoidoscopy if under the age of 50 provided there is no history of rectal bleeding, weight loss, or anemia; * bmi must be greater than/equal to 18.5 and less than 35.0; * successful completion of physical exam, 12-lead ecg, clinical laboratory tests prior to first dose of study medication; * vital signs must not have clinically-significant findings within 4 hours of first dose of study medication; * patient reports 3 or less spontaneous bowel movements (sbms) per week and meets 1 or more of the following criteria for constipation for 12 weeks in the previous 12 months: straining at least 25% bowel movements (bms), lumpy or hard stools at least 25% of bms, or sensation of incomplete evacuation at least 25% of bms; * patient reports 3 or less sbms during the 7-day pre-treatment period; * patient is compliant with ivrs for at least 6 days in the 7-day pre-treatment period. exclusion criteria: * use of investigational drug within 30 days; * laxative/enema-induced diarrhea within 60 days; * patient meets rome ii criteria for functional diarrhea; * most bothersome symptom is moderate or severe abdominal pain or abdominal discomfort; * history of cancer, inflammatory bowel disease, ischemic colitis, bowel resection, colostomy, or fecal impaction; * diagnosis of cathartic colon or laxative/enema abuse, pelvic floor dysfunction, evacuation disorder, bulimia, anorexia, or neurological disorders; * surgery within 30 days or gi surgery within 6 months of first dose of study medication. cholecystectomy and/or appendectomy are acceptable if completed more than 60 days prior to first dose of study medication; * patient may not use any disallowed medications (prescription and/or over-the-counter treatments for chronic constipation or c-ibs, drugs that target 5-ht4, 5-ht2b, or 5-ht3 receptors, narcotics, anti-cholinergic agents, gi preparations, etc.) during the 7-day pre-treatment period or during the study. stable, continuous (30 days or more) use of dietary fiber is acceptable. * any acute or chronic condition that would limit the patient's ability to complete and/or participate in the study.

Keywords: chronic constipation chronic idiopathic constipation constipation cic cc md-1100 md-1100 acetate microbia microbia, inc. linaclotide linaclotide acetate
the effect of different reconstruction methods on anterior resection syndrome

Conditions: Rectal Cancer; Low Anterior Resection Syndrome

Summary: the incidence of prerectal resection syndrome (lars) after middle and low rectal cancer surgery is as high as 70%, which seriously affects the quality of life of patients. studies have shown that colon pouch can reduce and alleviate lars symptoms. however, most previous studies focused on open surgery, and the evaluation index lacked objectivity. therefore, in the context of minimally invasive rectal cancer surgery, it is necessary to re-evaluate the value of improved surgical methods for the prevention of lars, so as to improve the quality of life of patients.

the incidence of prerectal resection syndrome (lars) after middle and low rectal cancer surgery is as high as 70%, which seriously affects the quality of life of patients. lars may be related to the injury of anal internal sphincter, anal sensory nerve injury, defecation reflex pathway injury, changes in anorectal angle and rectum sigmoid angle, changes in new rectal sensory function and compliance, and changes in dynamics,etc. after ar surgery, the rectum loses its good compliance and the storage capacity is reduced, which is one of the important reasons for the increased frequency and urgency of defecation.therefore, on the basis of traditional colon-rectum (or anal canal) end-to-end anastomosis, "j" shaped pouch anastomosis, end-to-end anastomosis, coloplasty and other special anastomosis methods were performed. meanwhile, for the lack of objective evaluation index, the results were not credible. the lars score was first published in 2012,and has been validated, evaluated, or used as an outcome measure in more than 30 published scientific papers. further more,laparoscopic surgery is widely used in gastrointestinal surgery. herein, current randomized controlled trial comparing coloplasty with straight colorectal anastomosis in lars in order to guide clinical practise was conducted.

Eligibility criteria:
inclusion criteria: * 20 years old ≤80 years old, regardless of gender, signed informed consent, * bmi≤kg/m\^2, * primary rectal lesions are pathologically diagnosed as rectal adenocarcinoma by endoscopic biopsy, * the distance between the tumor and the anal margin is 5cm to 12cm, * preoperative tumor stage is t1-4n0-3m0,(according to ajcc-8th tnm tumor staging), * normal anorectal function and lars score ≤20. exclusion criteria: * patients with inflammatory bowel disease, chronic constipation, irritable bowel syndrome and other intestinal diseases that may affect bowel function, * patients with large tumors or extensive invasion of surrounding tissues and organs, tme is not applicable, * long-term use of drugs (such as morphine) that may affect bowel function, * patients with a history of abdominal, pelvic and anorectal surgery, * patients with severe mental illness or who cannot be evaluated due to cultural or psychological reasons.

Keywords: rectal cancer